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OpenTrials
Active, Not Recruiting

NCT Number: NCT04797364

Pharmacogenetic Supported Prescribing in Kids

Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

About this study

Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.

Our objectives are to:

  • Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
  • Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
  • Establish a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical records available
  • The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
  • Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing

Exclusion criteria

  • Medically unstable or lacking capacity to provided informed consent
  • Unwillingness of child to provide saliva sample for genetic analysis
  • History of liver or bone marrow (hematopoietic cell) transplant

Treatment and study plan

Pharmacogenetic Testing

Diagnostic Test

Participants will donate a 2ml (teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) developed by our group and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the child's current and future care

Primary outcomes

  1. Adverse drug reactions

    Time frame: 6-months

    Relative change in adverse drug reaction frequency

  2. Symptom severity

    Time frame: 6-months

    Relative change in symptom severity

Secondary outcomes

  1. Healthcare utilization

    Time frame: 6-months

    Relative change in healthcare utilization

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: PGx-SParK

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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